NEWPORT, Ky., Aug. 5 KY-Xanodyne-Trial-NDA
NEWPORT, Ky., Aug. 5 /PRNewswire/ -- Xanodyne Pharmaceuticals, Inc.
announced today positive top line results in two pivotal Phase 3 clinical
trials of its proprietary investigational product, a modified-release (MR)
formulation of tranexamic acid for the treatment of women with menorrhagia, or
heavy menstrual bleeding, and its accompanying symptoms.
"We are extremely pleased with the initial data from these pivotal trials
and we look forward to continuing to work with the U.S. Food and Drug
Administration (FDA) to complete the registration process for what we hope may
be an important new therapeutic approach to treating this disabling
condition," said Gregory D. Flexter, President and Chief Executive Officer of
Xanodyne.
In addition to these two recently completed Phase 3 clinical trials, which
evaluated the efficacy and safety of tranexamic acid MR, two additional
open-label safety trials are ongoing. The four clinical trials represent the
basis for Xanodyne's planned filing of a new drug application (NDA) with the
FDA.
In each of the two placebo-controlled efficacy and safety trials, patients
treated with tranexamic acid MR experienced a significant reduction in mean
monthly menstrual blood loss compared with baseline pre-treatment blood loss,
during three and six cycles of treatment (p<0.0001), respectively. This
reduction was further judged to be meaningful by the women in the trials.
Further analysis of the complete safety and efficacy data from these four
trials is on-going.
"The achievement of this important clinical milestone for tranexamic acid
MR is a significant advance in our efforts to bring forward an important
treatment option for women suffering from menorrhagia. We are hopeful that
this product candidate, along with the pro-drug of tranexamic acid that we
recently licensed from XenoPort, Inc., may provide healthcare providers and
patients with the potential for a series of future treatment options for
serious conditions impacting the health of women," said Gary A. Shangold, MD,
Chief Medical Officer of Xanodyne.
Xanodyne is currently targeting the submission of an NDA in early 2009.
If ultimately approved, this product candidate could become the first approved
pharmaceutical product in the United States specifically indicated for the
treatment of menorrhagia.
About Menorrhagia
Heavy menstrual bleeding, or menorrhagia, represents a frequent and
significant medical condition encountered by obstetricians, gynecologists and
primary care physicians. Menorrhagia has been described as regular, normal
intervals of menstruation with volume that may exceed 80 milliliters of blood
loss per menstrual cycle.
About Xanodyne
Xanodyne Pharmaceuticals, Inc., which commenced operations in 2001, is an
integrated specialty pharmaceutical company with both development and
commercial capabilities focused on women's healthcare and pain management.
Xanodyne markets a portfolio of revenue generating products consisting of FDA
approved pharmaceuticals and a line of prenatal vitamins. Additionally,
Xanodyne is advancing a late stage pipeline of product candidates targeted at
significant potential markets in Xanodyne's focus areas.
SOURCE Xanodyne Pharmaceuticals, Inc.
